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#ORPH Open Orphan – Wellcome publication

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes a key considerations document for developing and manufacturing challenge agents published in the Wellcome Open Research Journal co-authored by Alex Mann, Senior Director of Clinical Research of hVIVOand the project lead, a subsidiary of Open Orphan plc, titled ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’.

The project was funded by the Wellcome Trust and HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines, based at Imperial College London. The considerations document was prepared by an hVIVO led consortium, involving engagement with global experts in the human challenge field and manufacturing. It outlines the key aspects of the development, characterisation and manufacture of infectious challenge agents. The aim of the document is to promote volunteer safety whilst maximising access to challenge agents and challenge models in low-income or middle-income countries (LMICs) and academic institutions globally.

It is hoped that these considerations will be used across high-, middle- and low-income countries for the safe production of challenge agents by trained personnel with appropriate facilities, quality control measures and other best practices.

The increase in human challenge studies being established in LMICs and the need for challenge agents to reflect naturally occurring and epidemiologically relevant pathogen strains means there is an increased likelihood that they will be manufactured in conditions where full Good Manufacturing Practice (“GMP”) is not possible. This document fills the previous gap of clear guidance on the minimum requirements for high-quality and safe manufacture outside of GMP facilities.

Challenge agents are the viruses, parasites, bacteria used in human challenge trials that volunteers are purposely challenged with. Depending on the design of the trial, the volunteers may or may not be administered a trial drug candidate before or after being exposed to the challenge agent to provide early proof of concept, allowing the candidate to progress more quickly to phase II or phase III trials.

Wellcome Open Research provides all Wellcome researchers with a place to rapidly publish any results they think are worth sharing. All articles benefit from rapid publication, transparent peer review and editorial guidance on making all source data openly available.

Yamin Khan, Chief Executive Officer of Open Orphan, said:  “As the world leader in conducting human challenge studies I am delighted that Open Orphan continues to play a key role in democratising access to human challenge trials. This latest document provides clear considerations for challenge agent manufacturing, where previously a gap existed regarding the minimum requirements for high-quality safe manufacture outside of GMP facilities. Human challenge trials have clear advantages over traditional clinical field trials, and their global adoption will be vital to progressing the development of vaccines and anti-infectives around the world.”

 

Alex Mann, Project leader and Senior Director, Clinical Science at hVIVO, said: “I was pleased to co-author the considerations document and the associated summary publication in collaboration with the Wellcome Trust and HIC-Vac, that recommends key aspects for researchers to consider for challenge agent development and manufacturing. In recent years, there has been an increase in human challenge studies in low- or middle-income countries where GMP facilities are not readily available. This document will support the development, characterisation and manufacture of challenge agents in these settings, while also maximising volunteer safety and access to challenge agents and challenge models.”

 

Shobana Balasingam, Research Lead in Infectious Disease Prevention at Wellcome, said: “The guidance to manufacture safe and effective challenge agents under GMP conditions differs globally and is not always feasible, which can slow down vital research, particularly in low- and middle-income countries where this research is often most-needed. However, guidelines for manufacturing outside of GMP facilities are not currently available.

 

“As funders of global infectious disease research, Wellcome are please to support this clear and practical document for developing challenge agents where GMP is not possible. This guidance can ensure the full potential of human infection studies around the world, which provide crucial insight into infectious diseases, helping to rapidly accelerate the development of vaccines.”

 

An editorial will be published alongside the report: ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’ by Shobana Balasingam, Sarah Meillon, Cecilia Chui, Alex Mann, Carine La, Charlie Weller, Debbie King and Emma Smith. Available in Wellcome Open Research. DOI: https://doi.org/10.12688/wellcomeopenres.17869.1

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

#ORPH Open Orphan – Challenge virus manufacturing contract

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO , a subsidiary of Open Orphan, has signed a substantial contract with an existing top 5 global pharmaceutical client to manufacture a virus for use in human challenge studies.

 

Virus manufacturing activities have commenced and are expected to be completed by end of Q3 2022. The Company is optimistic that a characterisation study and a substantial human challenge study would follow the completion of the GMP-compliant manufacturing process. The aim of a characterisation study is to establish the right dose of the virus that causes a safe and reliable infection in healthy volunteers. The revenue for the manufacturing process will be recognised in 2022.

 

The manufacture of new challenge viruses ensures that hVIVO has contemporary challenge agents available to meet the needs of the global pharmaceutical industry as they continue to fight the battle against infectious disease. Furthermore, this ensures the Company continues to enhance and expand its offering of human challenge studies, especially among infectious diseases where variants continually emerge and are often poorly understood.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We are delighted to have secured this challenge virus manufacturing contract, from an existing Big Pharma client. This contract is testament to our world-class capabilities in the entire challenge trial process, beginning with virus manufacture, through to characterisation study and challenge study execution. This contract illustrates our ability to leverage this to build deep, long-lasting relationships with our clients over significant periods of time.

“This contract is also a further example of the Company’s ability to secure repeat contracts from its existing base of Big Pharma clients, who have great confidence in our decades of world leading clinical trial experience. With this experience coupled with our expanded offering following the facilities expansion, I look forward to providing further clinical services support to the significantly enlarged and growing infectious and respiratory disease market.”

 

The Company also confirms that it has no plans to delist and is working with Liberum to complete their due diligence following their appointment as Nominated Adviser to the Company. It looks forward to confirming the completion of the required due diligence in due course.

The wording included in the announcement dated 28 April 2022 announcing the appointment of Liberum as Nominated Adviser was standard wording for all former clients of Arden Partners given the relatively short notice provided to the Company to appoint and complete take-on of a new Nominated Adviser following the recommended takeover of Arden Partners by The Ince Group plc.

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

Individuals interested in taking part in  COVID-19 human challenge study  research can learn more at   www.UKCovidChallenge.com .

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

#ORPH Open Orphan – New Malaria Human Challenge Model Launched

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials announces that further to the announcement on 9 August 2021, hVIVO, a subsidiary of Open Orphan, has inoculated the first cohort of volunteers with a GMP-manufactured malaria challenge agent as part of its first controlled human malaria infection (CHMI) challenge study. This study will assess CHMI using existing standard of care antimalarial drugs against Plasmodium malaria.

 

The study, which is taking place at hVIVO’s state-of-the-art facilities in London, is expected to complete in Q1 2022 with results in Q2 2022. For the study, hVIVO has leveraged its extensive experience in clinical trial recruitment, via its clinical trial recruitment arm FluCamp, to identify and screen volunteers to rapidly enrol the study cohort. Following the successful completion of the study, hVIVO will be able to sign malaria human challenge study contracts to assess the efficacy of novel antimalarial drugs and vaccines as well as correlates of immunity using a Plasmodium challenge agent.

 

hVIVO’s Direct Venous Inoculation (“DVI”) clinical trial protocol was reviewed by all necessary UK regulatory bodies and fully approved prior to the start of the study. Expert diagnostic services from the London School of Hygiene and Tropical Medicine have been contracted to monitor the welfare of subjects and provide essential correlates relating to drug and vaccine efficacy. Additionally, comprehensive training programmes have been completed by staff and senior professional oversight put in place for the review of scientific and safety data.

 

This malaria challenge model consists of inoculating volunteers with purified, infectious P. falciparum (Pf) sporozoites, harvested from the salivary glands of Anopheles stephensi mosquitoes. This type of malaria challenge model has been safely used in multiple clinical trials in the United States, Europe and Africa.

 

Conducting malaria modelling with Plasmodium in antimalarial drug and vaccine trials has several potential advantages over traditional methods of P. falciparum infected mosquito challenge, including superior predictability, a cleaner safety profile and improved control over levels of infection.

 

Learn more about hVIVO’s Malaria human challenge model here www.hvivo.com/clinical-development-services/hvivo-challenge-models/malaria/ or if you are interested in participating in a Malaria human challenge study or any other human challenge study visit www.flucamp.com

 

Adrian Wildfire, Director of Scientific & Business Strategy at hVIVO, said: Malaria is a disease of significant unmet need around the world, with 241 million cases and 627,000 deaths caused in 2020. Its prevention and cure is a designated World Health Organization target. As such, we are pleased to have commenced this study to allow our clinical teams to better acquaint themselves with the recently established Controlled Human Malaria Infection model, ahead of using human challenge studies to test our clients’ malaria products. Data resulting from such studies translates well into the field and malaria human challenge studies have been pivotal to the development of many of the novel drugs now entering late phase trials.

 

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to have inoculated the first cohort of volunteers for the Malaria study at our QMB facility in London. hVIVO is fully committed to growing the malaria model’s capabilities and capacity over the coming years to meet the challenge of accelerating the introduction of novel, safe and effective drugs and vaccines to the market.

 

“This study also ensures that Open Orphan is both strengthening and further diversifying the Company’s world leading portfolio of viral challenge models. We look forward to updating the market in due course.”

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

 

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)   +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
 
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard Chambers
 
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
 
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis Ashe-Jepson +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393

#POLB Poolbeg Pharma – Poolbeg Pharma licences first-in-class broad spectrum RNA-based immunotherapy for respiratory virus infections from the University of Warwick

17 January, 2022- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has in-licenced a novel, first-in-class RNA-based immunotherapy for respiratory virus infections developed at the University of Warwick.

Poolbeg has secured an exclusive licence to this dual antiviral prophylactic and therapeutic candidate, which is at a late-pre-clinical development stage. In vivo data confirms that this immunotherapy asset targets pan-respiratory virus infections, which could include influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.

The candidate, which will be developed by Poolbeg as POLB 002, was developed at the University of Warwick and derived from twenty years of research with world class virologists, Professor Andrew Easton and Professor Nigel Dimmock.

Administered intra-nasally, this RNA-based immunotherapy works by triggering nasal cells into an antiviral state to protect from the infecting virus. Simultaneously, it blocks the cells from making more virus by directly preventing its replication. Both modes of action combined can reduce infectious viral loads and improve disease symptoms. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations (e.g. the elderly, COPD patients, and asthmatics).

Respiratory virus infections are considered a top five global killer resulting in more than three million annual deaths worldwide. There is a significant unmet need for improved respiratory virus infection therapies and the current available treatments, vaccines and antiviral drugs, are typically pathogen specific. Consequently, 85% of illnesses caused by non-influenza viruses cannot be adequately treated and the emergence of resistance is also a major concern.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This dual action immunotherapy developed by the team at University of Warwick is a really exciting technology in the field of respiratory virus disease treatments. The data shows it to rapidly reduce viral load and also prevent the likelihood of virus resistance.

“It will be an excellent addition to our growing pipeline of assets and we plan to move rapidly towards human proof-of-concept studies using our capital light clinical model. We look forward to updating the market as POLB 002 progresses through the clinic with the ultimate aim of partnering it with Big Pharma.”

Professor Andrew Easton, from the School of Life Sciences at the University of Warwick, said: “Currently most respiratory virus infections cannot be treated despite being responsible for millions of deaths each year. This is a very exciting new approach with great potential. We are delighted to be developing it alongside the Poolbeg Pharma team, with their extensive knowledge and experience in the sector.”

– Ends –

Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 

+353 (0) 1 644 0007
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson

 

+44 (0) 20 7220 0500
Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

University of Warwick
Alice Scott – Media Relations Manager

+44 (0) 7920 531 221

Alice.j.scott@warwick.ac.uk

 

#POLB Poolbeg Pharma – Shares Spotlight

Take a look at this issue of shares spotlight which features Poolbeg Pharma on page 14-15.

#POLB Poolbeg Pharma – Scientific Advisory Board Appointment

25 November, 2021- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has appointed Professor Daniel Hoft to its Scientific Advisory Board .

Prof Hoft, M.D., Ph.D. is the Dianna and J. Joseph Adorjan Endowed Chair of Infectious Diseases and Immunology, and Director of the Division of Infectious Diseases, Allergy & Immunology at Saint Louis University (SLU) School of Medicine. He has been working in immunology and infectious diseases for 32 years. Prof Hoft has published over 140 peer reviewed scientific publications.

Prof Hoft will join the Scientific Advisory Board alongside Dr Elaine Sullivan and Prof Luke O’Neill and with his extensive background in infectious disease, immunology, and vaccinology, will guide the Company on its asset development programmes. Prof Hoft will also work with the Company to scout for prospective in-licencing opportunities.

Prof Hoft is heavily involved in vaccine development research, especially for pandemic influenza and tuberculosis which has seen him undertake pioneering work in T-cell targeting vaccines which is particularly relevant to the Company’s Vaccine Discovery Platform. He is Principal Investigator of the SLU’s Vaccine & Treatment Evaluation Unit (VTEU), one of ten US National Institutes of Health (NIH) centers, placing it among an elite group of top academic centers conducting clinical trials of novel vaccines for global protection against future pandemic challenges. Since the SARS-CoV-2 pandemic the SLU VTEU led by Prof Hoft has featured prominently in the urgent COVID-19 vaccine development and Prof Hoft is the VTEU protocol chair for a first-in-human phase I trial of a novel COVID-19 vaccine. He has received numerous awards from NIH, US Department of Defense, and the Bill & Melinda Gates Foundation and is a regular advisor to the World Health Organisation.

Read Prof Hoft’s full bio on Poolbeg’s website .

Jeremy Skillington, PhD, CEO of Poolbeg Pharma,  said: “Prof Hoft is a great addition to the Poolbeg Scientific Advisory Board, joining Dr Elaine Sullivan and Prof Luke O’Neill. His expertise in infectious disease, particularly with severe influenza and vaccine development will be invaluable as we develop Poolbeg’s pipeline of assets. He will also work with the Company to scout for prospective assets to in-licence and develop. Prof Hoft is a widely respected specialist within our industry and we look forward to working with him as we continue our growth journey.” 

Prof Daniel Hoft, M.D., Ph.D., commented:

“Poolbeg has an interesting portfolio of assets within infectious disease with an exciting lead asset, POLB 001. Coupled with its unique access to 20 years’ of human viral challenge study data, means its approach has real potential in this space. I look forward to helping support the business as it develops.”

– Ends –

 Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+353 (0) 1 644 0007

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard Chambers, Sunila de Silva (ECM)

 

 

+44 (0) 20 7220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

#ORPH Open Orphan – £1.5m Contract renewal for Venn Life Sciences

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that Venn Life Sciences (“Venn”), a subsidiary of Open Orphan, has signed a contract renewal with a major global pharmaceutical client worth £1.5m over two years.

The renewed contract will commence in January 2022, with the Venn team in Breda providing dedicated clinical pharmacokinetics (‘PK’) support to this leading global pharmaceutical client on an array of drug development programmes, to study the absorption, distribution, metabolism and excretion of drugs within the body.

Venn, which has been a part of Open Orphan since 2019, offers a combination of drug development consultancy, clinical trial design and execution. These combined services enable Venn to provide its clients with a complete end-to-end service on all the stages of their drug development programmes, from the early planning phase to final execution. Venn has offices in Breda (Netherlands) and Paris (France).

 

Cathal Friel, Executive Chairman of Open Orphan, said:  “We are delighted to see this contract renewal signed by the Venn team in Breda with a client that it has been working with since 2012. The continued support by Venn to a distinguished partner such as this demonstrates the value of Venn’s clinical pharmacokinetics offering, as part of its comprehensive offering in drug development consultancy, clinical trial design and execution. 

“Open Orphan’s strengths lie in the established relationships we have with our pharmaceutical partners and we expect to continue to develop these relationships as well as focusing on converting our existing pipeline of new business opportunities.”  

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 

Open Orphan Plc (ORPH) Directorate Changes

Open Orphan, a European-focussed, rare and orphan drug consulting services platform, is pleased to announce the appointment to the board of David Kelly as an Independent Non-Executive Director.

David has extensive orphan drug company experience both in Europe and in the USA. He was Executive Vice President and Managing Director of Ireland at Horizon Therapeutics plc, a biopharmaceutical company listed on Nasdaq and headquartered in Dublin. David has an excellent combination of experience having worked in larger product focussed pharmaceutical companies and also in turning around smaller pharmaceutical companies. For example, he and his colleagues transformed AGI Therapeutics before selling it to Vidara Therapeutics which in turn was acquired by Horizon Therapeutics plc, a company with a current market capitalisation of $4.5 billion.

David also served as Senior Vice President of Warner Chilcott, a fully integrated specialty pharmaceutical company. While at Warner Chilcott, he led the company’s successful IPO on Nasdaq. In addition, David also held roles in Elan Corporation and KPMG.

With David joining the Board and following the completion of the Company’s acquisition of Open Orphan DAC, Tony Richardson has stepped down from the Board with effect from today. The Company would like to thank him for his service as a Director.

Professor Brendan Buckley, Chairman, Open Orphan, commented:

“We are delighted that David is joining the Board of Open Orphan. He has extensive experience in the orphan drug market and we are looking forward to having David work closely with management going forward as we seek to rapidly grow the company.”

The following additional information is provided in accordance with paragraph (g) of Schedule Two to the AIM Rules for Companies and paragraph (g) of Schedule Two of the Euronext Growth Rules for Companies:

 

Full name: David George Kelly

Age: 58

Current Directorships / Partnerships:  Iterum Therapeutics plc, Iterum Therapeutics International Limited, Andromeda Biotech Limited, Horizon Pharma Israel Holding Corp. Limited, Horizon Pharma Investment Limited, Horizon Pharma Ireland Limited.

Past Directorships / Partnerships (past 5 years):  Horizon Pharma GMBH, Horizon Pharma Rheumatology Limited, Horizon Pharma Switzerland GMBH, Horizon Pharma Finance S.A.R.L, Horizon Pharma Services Limited, Horizon Pharma Finance Limited, Horizon Pharma Holdings 2 Limited, Hyperion Therapeutics Ireland Operating Limited, Hyperion Therapeutics Ireland Holdings Limited, Horizon Pharma Treasury Limited, Horizon Pharma Holdings Limited, Horizon Pharma Capital Limited, Hyperion Therapeutics International Operating Limited, Hyperion Therapeutics International Holdings Limited, Horizon Therapeutics plc, Horizon Pharma Aon Limited, Horizon Pharma Trí Limited, Horizon Pharma Dó Limited.

Enquiries:

Open Orphan Plc Tel: +353 (0)1 644 0007

Cathal Friel, Chief Executive Officer

Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900

John Llewellyn-Lloyd / Ruari McGirr / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363

Anthony Farrell (Corporate Finance)

Camarco (Financial PR) Tel: +44 (0)20 3757 4980

Tom Huddart / Billy Clegg / Daniel Sherwen

Notes to Editors:

Open Orphan plc is a European-focussed, rare and orphan drug consulting services platform. The Company consists of four elements: a European clinical research organisation and consultancy; an orphan drug services business; a Virtual Rep and Data Access Platform consisting of physicians and key opinion leaders; and a Health Data Platform to partner with Patient Advocacy Groups. The Company is targeting rapid growth in one of the fastest growing sectors in the global pharmaceutical industry targeting under-supplied treatment for life threatening or very serious diseases and rare disorders.

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